Trial Outcomes & Findings for Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons (NCT NCT00960414)
NCT ID: NCT00960414
Last Updated: 2024-07-24
Results Overview
weight loss at 18 month visit, approximately one year post-intervention completion, using attention-to-treat analyses of observed data
COMPLETED
NA
194 participants
18 months
2024-07-24
Participant Flow
We recruited participants for a weight loss study comparing two programs involving diet, exercise, and stress management from the community using fliers, newspaper advertisements, online postings, and referrals at UCSF clinics. Participants were enrolled in 6 rounds from July 2009-February 2012. Assessments were completed in October 2013.
Participant milestones
| Measure |
SHINE A
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
SHINE B
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
94
|
|
Overall Study
COMPLETED
|
81
|
67
|
|
Overall Study
NOT COMPLETED
|
19
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons
Baseline characteristics by cohort
| Measure |
SHINE A
n=100 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
SHINE B
n=94 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 13.0 • n=99 Participants
|
46.8 years
STANDARD_DEVIATION 12.4 • n=107 Participants
|
47.0 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
65 participants
n=99 Participants
|
50 participants
n=107 Participants
|
115 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
8 participants
n=99 Participants
|
11 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latina/Latino
|
7 participants
n=99 Participants
|
16 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=99 Participants
|
3 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Education
|
69 participants with bachelor's degree
n=99 Participants
|
56 participants with bachelor's degree
n=107 Participants
|
125 participants with bachelor's degree
n=206 Participants
|
|
Body Mass Index
|
35.4 kg/m^2
STANDARD_DEVIATION 3.5 • n=99 Participants
|
35.6 kg/m^2
STANDARD_DEVIATION 3.8 • n=107 Participants
|
35.47 kg/m^2
STANDARD_DEVIATION 3.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Two women in Arm B had weight-related variables censored at 18 months due to pregnancy.
weight loss at 18 month visit, approximately one year post-intervention completion, using attention-to-treat analyses of observed data
Outcome measures
| Measure |
SHINE A
n=81 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
SHINE B
n=65 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
|---|---|---|
|
Change in Weight From Baseline to 18 Months
|
-5.0 kg
Standard Deviation 0.9
|
-3.2 kg
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 0, 18 moPopulation: Two women in Arm B had weight-related variables censored at 18 months due to pregnancy.
change in waist circumference from baseline to 18 mos
Outcome measures
| Measure |
SHINE A
n=81 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
SHINE B
n=65 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
|---|---|---|
|
Fat Distribution
|
-4.8 cm
Standard Deviation 0.9
|
-3.6 cm
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 18 moPopulation: 2 participants in Arm A and 1 participant in Arm B did not have the lab results needed to calculate HOMA-IR at 18 months.
change in HOMA from baseline to 18 months. HOMA-IR is a validated assessment of insulin resistance. HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Outcome measures
| Measure |
SHINE A
n=79 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
SHINE B
n=66 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
|---|---|---|
|
Insulin Sensitivity
|
-.011 units on a scale
Standard Error 0.23
|
0.50 units on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 18 moPopulation: 8 participants in Arm A and 3 in Arm B did not complete this self-report survey at 18 months.
Change in Perceived Stress Scale scores from baseline to 18 months (i.e. approximately one year post-intervention completion), using intention-to-treat. Scores range from 0-40, with higher scores indicating higher perceived stress (worse outcome).
Outcome measures
| Measure |
SHINE A
n=73 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
SHINE B
n=64 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
|---|---|---|
|
Change in Perceived Stress From Baseline to 18 Months
|
-1.03 units on a scale
Standard Error 0.57
|
-0.11 units on a scale
Standard Error 0.61
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 8 participants in Arm A and 3 in Arm B did not complete this self-report survey at 18 months.
We used the 10-item positive emotions subscale of the Differential Emotions Scale (DES; Izard et al., 1991) to assess the extent to which a participant experienced positive emotions in the prior week. Participants responded on a five-point scale (0 = not at all, 4 = extremely; total score possible range 0-40). We summed items to create a total score, with higher scores indicating more positive emotions.
Outcome measures
| Measure |
SHINE A
n=73 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
SHINE B
n=64 Participants
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
|---|---|---|
|
Change in Positive Emotions Subscale of the Differential Emotions Scale
|
2.49 score on a scale
Standard Error 0.67
|
-0.21 score on a scale
Standard Error 0.70
|
SECONDARY outcome
Timeframe: 0, 6, 12 moOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 3,6,12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 6 moOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
Outcome data not reported
Adverse Events
SHINE A
SHINE B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rick Hecht, MD
UCSF Osher Center for Integrative Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place